- Device
- PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P990081
- Supplement
- S047
- Product code
- MVC
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Decision date
- 2022-09-30
- Decision code
- APPR
- Date received
- 2022-05-27
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody for expanding the indications to include testing for breast cancer patients who are eligible for treatment with ENHERTU®.